16 Month Survival Advantage w/Intraperitoneal Chemo (Toxicity)

Intraperitoneal Cisplatin and Paclitaxel in Ovarian Cancer

Deborah K. Armstrong, M.D., Brian Bundy, Ph.D., Lari Wenzel, Ph.D., Helen Q. Huang, M.S., Rebecca Baergen, M.D., Shashikant Lele, M.D., Larry J. Copeland, M.D., Joan L. Walker, M.D., Robert A. Burger, M.D., for the Gynecologic Oncology Group

ABSTRACT

Background Standard chemotherapy for newly diagnosed ovarian cancer is a platinum–taxane combination. The Gynecologic Oncology Group conducted a randomized, phase 3 trial that compared intravenous paclitaxel plus cisplatin with intravenous paclitaxel plus intraperitoneal cisplatin and paclitaxel in patients with stage III ovarian cancer.

Methods We randomly assigned patients with stage III ovarian carcinoma or primary peritoneal carcinoma with no residual mass greater than 1.0 cm to receive 135 mg of intravenous paclitaxel per square meter of body-surface area over a 24-hour period followed by either 75 mg of intravenous cisplatin per square meter on day 2 (intravenous-therapy group) or 100 mg of intraperitoneal cisplatin per square meter on day 2 and 60 mg of intraperitoneal paclitaxel per square meter on day 8 (intraperitoneal-therapy group). Treatment was given every three weeks for six cycles. Quality of life was assessed.

Results Of 429 patients who underwent randomization, 415 were eligible. Grade 3 and 4 pain, fatigue, and hematologic, gastrointestinal, metabolic, and neurologic toxic effects were more common in the intraperitoneal-therapy group than in the intravenous-therapy group (P0.001).

Only 42 percent of the patients in the intraperitoneal-therapy group completed six cycles of the assigned therapy, but the median duration of progression-free survival in the intravenous-therapy and intraperitoneal-therapy groups was 18.3 and 23.8 months, respectively (P=0.05 by the log-rank test).

The median duration of overall survival in the intravenous-therapy and intraperitoneal-therapy groups was 49.7 and 65.6 months, respectively (P=0.03 by the log-rank test).

Quality of life was significantly worse in the intraperitoneal-therapy group before cycle 4 and three to six weeks after treatment but not one year after treatment.

Conclusions As compared with intravenous paclitaxel plus cisplatin, intravenous paclitaxel plus intraperitoneal cisplatin and paclitaxel improves survival in patients with optimally debulked stage III ovarian cancer.



Source Information

From the Johns Hopkins Kimmel Cancer Center, Baltimore (D.K.A.); the Gynecologic Oncology Group Statistical and Data Center (B.B., H.Q.H.) and Gynecologic Oncology (S.L.), Roswell Park Cancer Institute, Buffalo, N.Y.; the University of California, Irvine, Irvine (L.W.); the New York–Presbyterian Hospital, Weill Medical College of Cornell University, New York (R.B.); Ohio State University, Columbus (L.J.C.); the University of Oklahoma, Oklahoma City (J.L.W.); and the Division of Gynecologic Oncology, University of California, Irvine, Orange (R.A.B.).

Address reprint requests to Denise Mackey at the Gynecologic Oncology Group, Administrative Office, 4 Penn Ctr., 1600 JFK Blvd., Ste. 1020, Philadelphia, PA 19103, or at dmackey@gog.org.

NEJM Volume 354:34-43 January 5, 2006 Number 1

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